Eli Lilly and Company · 8 hours ago
Associate Director - IWRS Design and Development
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$116K/yr - $169K/yr
7+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering life-changing medicines. The Associate Director - IWRS Design and Development is responsible for overseeing the implementation of the Interactive Web Response System, ensuring compliance with clinical protocols, and collaborating with various teams to facilitate clinical research.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Study Setup process management and oversight • Partner with medical teams, key internal business partners, and third parties to enable clinical research
Leverage robust knowledge of multiple inventory methodologies to collaborate with Clinical Trial Study Management and facilitate optimal Supply Planning
Be an active and engaged member of the global trial development team influencing trial design and protocol language for all aspects of treatment assignment, dispensing, and associated data sets
Provide back-up support for Global Support Help Desk, if required, and respond to customers in a timely manner; act as primary resource for Help Desk personnel for study set-up and support questions
Maintain GMP/GCP compliance by following procedures applicable to clinical trial execution
Actively participate in external inspections and internal audits for responsible compounds and trials. Coordinate with Quality to ensure all preparation is complete and reviewed prior to inspection/audit start
Successfully operate in, and provide solutions to, complex working arrangements (CROs for particular functions; multiple distribution networks; etc.)
Coordinate the flow of information with multiple partners (Medical, Stats, IT, Data Movement, Product Delivery, etc.)
Manage the resolution of internet connectivity issues, which includes but is not limited to: working with clinical trial sites and CROs, collaborating with IT, providing status updates/resolution to study teams
Mentor and coach peers to enable their ability to support studies of increasing complexity
Foster an environment of integrated teamwork and partnership via shared learning, accountability, influencing others without authority
Drive innovation by identifying and proposing system enhancements to the IWRS to enable productivity gains and support the growing complexities of the portfolio
Consultation, study set-up and execution • Build and maintain strong business partnerships with teams, functions and affiliates
Serve as technical expert for all aspects of IWRS/IRT (e.g., randomization (including adaptive and advanced randomization), dispensing, inventory methodologies, etc)
Consult with and influence multiple functions during protocol development and the study build process, ensuring the IWRS study build supports the required capabilities while protecting the overall integrity of the study
+ Clinical Trial Project Managers – Assess patient management needs and implement an IWRS solution to simplify processing for increased site compliance
+ Statisticians – Influence study randomization methods, in particular, stratification factors and ratios, to ensure data collected and used during the trial is what was initially projected
+ Data Sciences – Collaborate to ensure that IWRS data meets the needs of the study and conforms to the standard data transfer methodologies / datasets. If necessary, propose changes to ensure that separate interfaces are not required to support a single trail design. As necessary, create reusable solutions to share information between systems such as eDC and central labs to eliminate redundancy and entry errors
Drive all aspects of the System Development Cycle to deliver validated, study-specific IWRS builds. This includes, but is not limited to:
+ Gathering and defining study-specific system requirements
+ Coordinating and executing study set-up process
+ Ensuring timelines are met to support the portfolio and enable FPV
Provide ongoing support and maintenance for all Lilly clinical trials utilizing IWRS
Provide consultation and expertise for studies utilizing a Third Party’s IWRS
Ensure confidentiality and blinding is appropriately maintained at all times
Process Improvement • Drive innovation by proactively identifying ways for process optimization to improve day-to-day activities and practices, and actively communicate opportunities to peers and leadership team
Participate in and/or support the implementation of local/divisional/corporate projects, critical chain, and process improvement initiatives
Take proactive measures to avoid or reduce crises. When emergencies occur, identify root cause of issues and communicate countermeasures and lessons learned
Qualification
Required
Bachelors degree and 3 years' experience in clinical trials (CDO, Product Delivery, etc.) and/or 7 years' experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.); alternatively, a high school diploma and 5 years' experience in clinical trials and/or 7 years' experience in drug development
Minimum of 2 years prior experience developing and supporting studies in IWRS/IRT
Preferred
Deep understanding of various clinical trial protocol designs and their relationship to IWRS development
Demonstrated effectiveness across teams and management levels to drive process improvements and influence decisions
Ability to build productive relationships and effectively communicate with functional leadership
Proven formal or informal project management capability (timeline, scope, resources, time management)
Demonstrated problem-solving skills for complex study designs and issues
Strong organizational and self-management skills
Strong relationship-management skills including working across multi-disciplinary global business partners as well as external vendors
Demonstrated strength in logical thought, problem solving ability and strategic thinking
Strong written and verbal communication skills in multi-cultural settings
Prior experience with third-party IVRS and/or IWRS systems
Deep understanding and ability to utilize multiple computer applications (e.g. IMPACT, CT-WIN, MS Office)
Exemplary teamwork/interpersonal skills
Must speak fluent English
Benefits
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (404)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2025-12-30
2025-12-30
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